Reporting to the Head of the Real World Evidence Center of Excellence, the Senior Director of Real World Evidence is responsible for establishing rigorous assessment of real world data to assess the natural history of diseases and real world outcomes for the Vertex early development and clinical portfolio. The Senior Director of RWE will shape and influence all aspects of global observational research, particularly the execution of observational research to inform development and regulatory strategies. These analyses inform the real world utilization and outcomes of Vertex therapeutics inform clinicians, payers, policy makers, patient groups and internal decision making.

General Responsibilities and Required Skills:
The Senior Director works cross-functionally as content expertise and tactical lead for the execution of observational research across the portfolio. The Senior Director oversees the strategic planning and execution of real world evidence conducted by RWE directors and their direct reports to ensure the timely delivery of scientifically valid epidemiology and observation research in rare diseases.

Key Responsibilities
Along with the Head of RWE, responsible for RWE leadership across key internal cross-functional leadership teams. Leverages advanced communication and translation skills, strategic planning, and consensus building across Regulatory, Biostatistics, Global Medical Affairs, Global Clinical Development, Early Clinical Development, Translational Medicine, Health Economics and Outcomes Research, International Medical Affairs, Market Access, Patient Advocacy and Digital Sciences.

• First line manager for RWE disease area directors across the portfolio
• Assess research gaps and objectives across key partners and disease areas to determine epidemiology/observational research strategy, research objectives and tactical plans for cross disease area projects, as well as appropriate differentiation strategies
• Possess superb communication skills, advanced multi-stakeholder experience, comprehensive understanding of Vertex business and development goals, and a highly-evolved capability to translate RWE methodology to diverse audiences
• Effectively manage internal and external stakeholder expectations regarding strategic objectives and execution of research
• Responsible for robust study concept development and execution of natural history of disease assessment for key disease areas/initiatives
• Cross-functional collaboration with Global Clinical Development to provide strategic and tactical leadership for developing RWD historical control and methods
• Establishing innovative methods and integrating into RWE, global safety and medical affairs observational research
• Identify opportunities for efficient development of innovative research initiatives and application across disease areas
• Ability to make compliant decisions and execute on those decisions in their research agenda within RWE standard operating processes and working documents
• Oversee RWE study leads\xe2\x80\x99 compliance with study conduct and tracking according to standard operating processes and working documents
• Proactively identify opportunities and initiate process improvements for optimal quality, cost, speed, innovation, efficiency and effectiveness
• Support VP & Head of RWE COE in developing and implementing operational processes for internal department as it relates to daily RWE activities
• Participate in multiple projects to ensure RWE capabilities are utilized, both cross-functionally and internally
• Serve as delegate for VP & Head of RWE COE on key teams including NiPPRC
• Oversee performance metrics and dashboards for RWE projects across the portfolio
• Assess real world data assets and establish real world data plan, including data licenses and data platforms, in collaboration with RWD Governance Committee

Minimum Qualifications:

• PhD in biostatistics, epidemiology, health economics and outcomes research, health policy, or similar required
• Formal training in Epidemiology/Health Services Research required
• At least 12+ years-experience in observational research study management AND data analytics, either within industry or with an observational research consulting firm
• Demonstrated leadership in global role leading strategy across multiple disease areas
• Demonstrated development of talented observational researchers within a matrix environment
• Solid understanding of global conduct of observational research, including privacy standards
• Advanced knowledge in observational research design
• Excellent interpersonal communication and study management skills
• Ability to take detailed observational study results and communicate them in a clear, non-technical manner to internal cross-functional teams, using language that resonates with the teams, while maintaining the integrity of key findings
• Ability to work effectively in a constantly changing, diverse, and matrix environment
• Strong working knowledge of the Microsoft Office Suite (Word, PowerPoint, Excel)

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Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person\'s race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.